IMDX Reports Q2 2025 Results and Momentum Toward GraftAssureDx Launch

Core Insights - Insight Molecular Diagnostics Inc. (iMDx) is progressing towards delivering a regulated kitted transplant monitoring assay, GraftAssureDx, to the market, aiming to capture a share of the $1 billion transplant rejection testing market [1][2][4] Regulatory and Product Development - The company is focused on designing a complex molecular lab test in a kitted form to facilitate localized diagnostic testing, with plans to submit GraftAssureDx for FDA review by the end of 2025 [2][7] - iMDx has made significant strides in its clinical trial, engaging leading transplant hospitals, and has received positive feedback from the FDA during meetings [8][11] - The company aims to democratize access to transplant rejection tests by obtaining regulatory authorization, allowing hospitals to conduct tests independently [4][6] Financial Performance - In Q2 2025, iMDx reported revenues of $518,000, primarily from laboratory services and initial sales of GraftAssureIQ kits, with a gross profit of $350,000, reflecting a gross margin of 67.6% [15][18] - Operating expenses for Q2 2025 totaled $10.2 million, with a net loss of $9.7 million, or ($0.30) per share, indicating ongoing investment in product development and regulatory processes [18][26] Market Strategy and Future Outlook - The company is implementing a "Land and Expand" strategy, starting with research-use-only kits to familiarize hospitals with their assays before transitioning to diagnostic kits upon regulatory approval [9][15] - iMDx is also exploring expansion opportunities beyond kidney transplant testing, including heart, lung, and liver transplant rejection testing, leveraging the same cfDNA platform [12][14] - The company has received a boost in Medicare reimbursement for its flagship technology, GraftAssureCore, which sets a benchmark for future kitted test reimbursement [8][9]